The current regulatory environment undermines opportunities for self-care and could compromise the vitality of the pharmacy sector, says Pharmacy Magazine clinical editor Mark Greener

Empowering self-care is, along with improved antibiotic stewardship and better preventative health, often one of those platitudes trotted out by politicians, pundits and pharmaceutical companies in search of a soundbite.

Yet a report from the Economist Intelligence Unit (EIU), commissioned by RB in association with the Proprietary Association of Great Britain (PAGB), argues that “an inconsistent regulatory environment” represents “an important impediment to continued growth of OTC drugs”.

The report notes that the top ten minor ailments were responsible for 75 per cent of consultation costs and 85 per cent of prescription costs in 2006-7. Back pain, the commonest minor ailment, accounted for 8.4 million consultations. Dermatitis and heartburn/indigestion together accounted for 13.6 million.

Writing in the report, John Smith, PAGB chief executive, suggested that if everyone with a self-treatable condition who attended a GP appointment or visited A&E “were to practise self-care, with the advice of a pharmacist if needed, it could save the National Health Service £2.3bn”.

Self-care depends on patients being able to access the treatments they need. The 15 experts interviewed by the EIU believed that regulatory differences across Europe probably “increase costs and impede patient access”, although there is a dearth of “solid research” about the extent of the impact.

For example, the claims companies can make, the outlets able to sell non-prescription drugs and whether a pharmacist needs to be present differ from country to country. Some European countries, for example, do not approve OTC drugs for migraine. Although there has been progress towards regulatory harmonisation, this has focused largely on prescription medicines rather than OTC products.

Different approach

In its commentary, RB suggests that the regulation of non-prescription medicines requires a different approach to POMs. The system needs to accept “that non-prescription medicines do not enjoy patent protection” and that the studies used to establish safety and efficacy “were not conducted to today’s standards”. However, safety and efficacy are “verified by many years of safe and effective use in the real world”.

RB suggests that imposing “today’s standards for new chemical entities onto non-prescription medicines is not necessary or consistent with a philosophy to find reasons to approve or expand access to medicines for self-care”. The company suggests that there are limited incentives (such as market exclusivity or data protection) to encourage product development, switch or reclassification to OTC.

Pharmacists must hope that regulators take action but regulatory reform isn’t enough. Patients need to understand how and when to self-care. A so-called ‘minor ailment’ isn’t necessarily trivial to the patient. Back pain can be a symptom of pancreatic cancer, for example. Indigestion could the first indication of gastric cancer. Obviously, watching for atypical presentations and red flags allows pharmacists’ clinical skills to come into their own.

Pharmacists are also ideally placed to help tackle the pervasive problem posed by health illiteracy. One study, for instance, assessed how well 7,857 adults aged 52 years and over understood written instructions for aspirin using four questions:
• What is the maximum number of days you may take this medicine?
• List three situations for which you should consult a doctor
• List one condition for which you might take the tablet
• List one condition for which you should not take the tablet.

A fifth (20.3 per cent) made one error and 12.5 per cent made more than one error. During a mean follow-up of 5.3 years, 6.1 per cent of those who did not make any error died, compared to 9.0 per cent of those who made one error and 16.0 per cent of those who made more than one error.

After adjusting for confounders, all-cause mortality was 40 per cent higher in those with low compared to high health literacy¹. The finding that a third of these adults had difficulties understanding the instructions on a packet of aspirin highlights just how much support some people need to self-medicate safely and effectively.

Not risk-free

It should also be remembered that self-care remedies are not risk-free. An audit of 100 acute medical emergency admissions to a Liverpool hospital found that 24 per cent took herbal medications. Most (83 per cent) took the herb concomitantly with at least one prescription medication.² While herbal and other traditional treatments can be important elements in self-care, patients need to tread carefully.

St John’s wort, for example, is best known as a herbal treatment for depression and anxiety. Patients may take St John’s wort for, among other ailments, sleep disorders, the common cold, herpes, as a topical analgesic, and as an enema for ulcerative colitis.³

However, combining St John’s wort and other serotonergic agents (e.g. selective serotonin reuptake inhibitors) can trigger the potentially fatal serotonin syndrome. St John’s wort can also interact with oral contraceptives leading to unplanned pregnancies and breakthrough bleeding.⁴

What this illustrates is that patients need support to avoid potentially serious interactions with self-care options.

It will be years before the eminently sensible regulatory changes proposed in the EIU report are enacted and new self-care products reach community pharmacists. In the meantime, the fall-out from Brexit isn’t clear. The report notes that the UK is “among the most open” countries to OTC medicines – but self-care depends on more than a diverse OTC armamentarium.

Patients, many of whom struggle with health literacy, need support and help to identify the right options and use them safely – and that depends on a vibrant and viable community pharmacy sector. If the Government’s proposed changes to the pharmacy sector cut as deeply as some fear, the potential of self-care could remain largely unrealised and the term could remain little more than yet another sound bite platitude.

To access the full report, click here.

<sup>References
1. BMJ 2012; 344:e1602
2. B J Clin Pharmacol 2007; 63:247-8
3. J Am Coll Card 2010; 55:515-25
4. B J Clin Pharmacol 2002; 54:349-56</sup>

Many patients struggle with health literacy and need help to identify the right options